Clinical Trial

A Study of Tirbanibulin Ointment and Diclofenac Sodium Gel for the Treatment of Adult Participants With Actinic Keratosis on the Face or Scalp

Study acronym: AKtive
Active, Not Recruiting Phase 4
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Summary
The purpose of the study is to evaluate the incidence of biopsy confirmed invasive squamous cell carcinoma (SCC) in the selected treatment field (TF) after administration of topical tirbanibulin 10 milligram (mg)/gram (g) ointment or diclofenac sodium 3 percent (%) gel over the 3-year study period.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2022-05-19; most recent amendment 2025-02-07.
Status change: Recruiting → Active, Not Recruiting 2025-02-07
Status change: Not Yet Recruiting → Recruiting 2022-11-03
Trial Details
NCT Number NCT05387525
Lead Sponsor Almirall, S.A.
Conditions Keratosis, Actinic
Enrollment 447 participants
Start Date 2022-10-24
Primary Completion 2027-07 (estimated)
Study Completion 2027-07 (estimated)
Updated on ClinicalTrials.gov 2025-02-11